MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR 3D KNEE; EMPOWR 3D KNEETM INS, 8L 14MM, VE

Model Number	341-14-708
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this complaint was reported as product being switched after the sterilization process.The healthcare professional indicated this event occurred during surgery, away from the patient and there was a significant adverse event to the patient.There was a four to five minutes delay in surgery but the surgery was completed as intended.The agent was present during surgery and had another suitable device available.The device was returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.A review of the device history records (dhr) indicate twenty (20) pieces of 942-01-40h, acetabular liner, lot 629z1085, were processed on work order (b)(4).These parts went through the sterilizer run (b)(4).Twenty (20) pieces of 341-14-709, knee insert, lot 132t1085, were processed on work order (b)(4).These parts went through the sterilizer on run (b)(4).Both work orders were processed by the same operator.The label on the bottom tray matches the work order and packaged part; however, the label on the front of the tray and outer packaging were swapped.Complaint database indicates one other instance occurring for the same product and lot numbers.The surgery took place on the same day.No prior complaints report past instances of these instruments being affected by this failure.The root cause of this complaint is likely due to the product being switched after the sterilization process.(b)(4) was opened to capture the containment process for this issue.Rma examination: the reported devices were returned to djo surgical for evaluation.It is confirmed that the packaging for the empowr 3d knee insert contained an acetabular liner.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Compliant - due to wrong implant inside of box.Upon opening box for a "l" size 8, 14mm knee insert, we discovered a hip poly liner inside.Slightly - had to retrieve 2nd insert.

• Brand Name: EMPOWR 3D KNEE
• Common Device Name: EMPOWR 3D KNEETM INS, 8L 14MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 14758088
• Report Number: 1644408-2022-00820
• Device Sequence Number: 14991004
• Product Code: JWH
• UDI-Device Identifier: 00888912167055
• UDI-Public: (01)00888912167055
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 341-14-708
• Device Catalogue Number: 341-14-708
• Device Lot Number: 132T1085
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Male